# FDA 483 - Shilpa Medicare Limited - September 06, 2019

Source: https://www.keypedia.com/records/483/shilpa-medicare-limited/454b93df-428c-4c44-a718-2062133d8ced

> FDA 483 for Shilpa Medicare Limited on September 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shilpa Medicare Limited
- Inspection Date: 2019-09-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Shilpa Medicare Limited in Polepally, India, a manufacturer of human drug products, was cited for deficiencies in its quality control laboratory. The inspection revealed that the firm did not follow its written stability testing program, leading to sample analyses exceeding allowed timelines. Additionally, insanitary conditions were observed for QC lab instruments and apparatus, contributing to a high rate of out-of-specification results.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

Company: https://www.keypedia.com/companies/shilpa-medicare-limited/9184777f-89bb-4a33-bcb2-4cc2aa4eb655

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1